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MAPK/ERK Kinase Inhibitor

Selumetinib for Cancer

Phase 2

Waitlist Available

Led By Carl E Allen

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621E based on the presence of an actionable mutation

Patients must have a body surface area >= 0.5 m^2 at enrollment

Must not have

Patients receiving certain concomitant medications

Patients with uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies selumetinib sulfate in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders.

Who is the study for?

This trial is for patients with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have MAPK pathway mutations and are not responding to treatment. Participants must be able to swallow capsules, have a body surface area >= 0.5 m^2, and meet specific health criteria including organ function and blood counts. Pregnant women or those on certain medications cannot join.

What is being tested?

The study tests Selumetinib Sulfate's effectiveness in treating relapsed or refractory cancers with MAPK mutations. It's a phase II trial aiming to see if this drug can halt cancer cell growth by inhibiting necessary enzymes.

What are the potential side effects?

Selumetinib may cause side effects such as fatigue, rash, nausea, vomiting, diarrhea, abdominal pain, visual changes and increased blood pressure. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am enrolled in APEC1621SC and assigned to MATCH based on a specific mutation in my cancer.

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My body surface area is at least 0.5 square meters.

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I am mostly able to care for myself and carry out daily activities.

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I have never been treated with selumetinib.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking other medications.

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I do not have any infections that are currently uncontrolled.

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I am not taking medication that strongly affects how my body processes drugs.

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I have been diagnosed with a low grade glioma.

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I am taking medication to prevent graft-versus-host disease after a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate

Secondary study objectives

Percentage of Participants With Treatment-related Adverse Events as Accessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0

Progression Free Survival (PFS)

Other study objectives

Biomarker Analysis as Predictors of Response to Selumetinib

Changes in Tumor Genomic Profile

Side effects data

From 2020 Phase 2 trial • 8 Patients • NCT03040986

100%

Aspartate aminotransferase increased

83%

Edema limbs

83%

Hypoalbuminemia

67%

Fatigue

67%

Hypertension

50%

Abdominal pain

50%

Anemia

50%

Dyspnea

50%

Alkaline phosphatase increased

50%

Anorexia

50%

Alanine aminotransferase increased

50%

Nausea

33%

Dizziness

33%

Hypocalcemia

33%

Generalized muscle weakness

33%

Hyponatremia

33%

Lymphocyte count decreased

33%

Rash maculo-papular

33%

Hypokalemia

33%

Bloating

33%

CPK increased

33%

Cough

33%

Creatinine increased

33%

Vomiting

17%

Heart failure

17%

Pancreatitis

17%

Diarrhea

17%

Dry mouth

17%

Colonic obstruction

17%

Confusion

17%

Gallbladder obstruction

17%

Gallbladder infection

17%

Lipase increased

17%

Serum amylase increased

17%

Ascites

17%

Dysgeusia

17%

Alopecia

17%

Edema trunk

17%

White blood cell decreased

17%

Atelectasis

17%

Dysphagia

17%

Glucose intolerance

17%

Hyperglycemia

17%

Weight loss

17%

Hypomagnesemia

17%

Hypotension

17%

Malaise

17%

Neck pain

17%

Pleural effusion

17%

Postnasal drip

17%

Renal and urinary disorders - Other, Dysuria

17%

Rash acneiform

17%

Neutrophil count decreased

17%

Paresthesia

17%

Peritoneal infection

17%

Back pain

17%

Biliary tract infection

17%

Blood bilirubin increased

17%

Fever

17%

Sore throat

17%

Urinary tract obstruction

17%

Musculoskeletal and connective tissue disorder - Other, muscle spasm

17%

Urine discoloration

100%

80%

60%

40%

20%

Study treatment Arm

Dose Level 0: 75mg Selumetinib Sulfate Twice Daily

75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (selumetinib)Experimental Treatment3 Interventions

Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selumetinib

2010

Completed Phase 2

~2080

Selumetinib Sulfate

2017

Completed Phase 2

~80